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Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen Clinical research trials and Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen. Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen clinical trial. Participants frequently get the best healthcare available for their Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.

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Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen



Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen

For Condition: HIV Infections
Status: Completed
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach before dissolving. The purpose of this study is to compare the effectiveness of an anti-HIV drug combination that includes ddI EC versus another anti-HIV drug combination.
Details: Patients are randomized to 1 of 2 groups for 48 weeks of open-label treatment. Group 1 receives ddI EC plus d4T plus NFV. Group 2 receives Combivir plus NFV. Antiviral activity is determined by the proportion of patients with HIV RNA levels of less than 400 copies/ml at Week 48.
Eligibility:
Study Type:
  Interventional, Treatment, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-positive. - Have a viral load of at least 2,000 copies/ml and a CD4 count of at least 200 cells/mm3. - Are at least 18 years old. - Agree to practice sexual abstinence or to use effective barrier methods of birth control (such as condoms). Exclusion Criteria Patients will not be eligible for this study if they: - Have had severe diarrhea within 30 days of study entry. - Have a history of pancreatic disease or any other serious condition. - Have hepatitis within 30 days of study entry. - Are diagnosed with an opportunistic (AIDS-related) infection at the time of enrollment. - Are unable to take medications by mouth. - Have received certain medications. - Are pregnant or breast-feeding.
Total Enrollment: 500

Location and Contact Information:

AIDS Healthcare Foundation
Los Angeles,  California,  900276069
United States
 

Gathe, Joseph, M.D.
Houston,  Texas,  77004
United States
 

Henry Ford Hosp
Detroit,  Michigan,  48202
United States
 

Clinique Medicale L'Actuele
Montreal,  Quebec, 
Canada
 

Dartmouth-Hitchcock Med Ctr
Lebanon,  New Hampshire,  03756
United States
 

Univ of Texas Southwestern Med Ctr of Dallas
Dallas,  Texas,  75235
United States
 

Sorra Research Ctr / Med Forum
Birmingham,  Alabama,  35203
United States
 

Montrose Clinic
Houston,  Texas,  77006
United States
 

Ohio State Univ Hosp Clinic
Columbus,  Ohio,  432101228
United States
 

San Francisco Gen Hosp
San Francisco,  California,  94115
United States
 

Med Alternatives
Ft. Lauderdale,  Florida,  33308
United States
 

The CORE Ctr
Chicago,  Illinois,  60612
United States
 

NJCRI
Newark,  New Jersey,  07103
United States
 

Clinique Medicale du Quartier Latin
Montreal,  Quebec, 
Canada
 

Hampton Roads Med Specialists
Hampton,  Virginia,  23666
United States
 

Dr Gerald Pierone Jr
Vero Beach,  Florida,  32960
United States
 

Body Positive
Phoenix,  Arizona,  85016
United States
 

Univ of Kansas School of Medicine
Wichita,  Kansas,  672143124
United States
 

County Line Med CtrInc
Pembrook,  Florida,  33023
United States
 

Infectious Disease Assoc of Central Jersey
Somerville,  New Jersey,  08876
United States
 

Indiana Univ Med Ctr
Indianapolis,  Indiana,  462025250
United States
 

Dr Roger P Leblanc
Montreal,  Quebec, 
Canada
 

Anderson Clinical Research
Pittsburgh,  Pennsylvania,  15213
United States
 


Additional Information:
Study ID Numbers:
  039F;  AI454-152
Study Start Date: July 1999
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002429

Other Hiv Infections Studies:
1. A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 mg q 8 h Versus 1,200 mg q 12 h in Combination with Zidovudine and 3TC

2. A Study of Peer Education to Prevent HIV Transmission among Injection Drug Users and Their HIV Risk Contacts

3. A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on their First PI-Based Antiretroviral Therapy

4. A Study of Zidovudine and T Lymphocyte Transfer in the Treatment of HIV Type III in Patients with AIDS

5. A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Infants and Children Infected With or at Risk for HIV Infection

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Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen

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